T2 STRATOSPHERE Expandable Corpectomy System
K-Number: K181328 · 2018-09-19
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2018-09-19
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
T2 STRATOSPHERE Expandable Corpectomy System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2018-09-19 under approval number K181328. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the T2 STRATOSPHERE Expandable Corpectomy System?
T2 STRATOSPHERE Expandable Corpectomy System is a medical device that received FDA 510(k) clearance on 2018-09-19. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K181328.
When was T2 STRATOSPHERE Expandable Corpectomy System approved by the FDA?
T2 STRATOSPHERE Expandable Corpectomy System received FDA 510(k) clearance on 2018-09-19, under approval number K181328.
What company makes T2 STRATOSPHERE Expandable Corpectomy System?
T2 STRATOSPHERE Expandable Corpectomy System is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for T2 STRATOSPHERE Expandable Corpectomy System?
The FDA product code for T2 STRATOSPHERE Expandable Corpectomy System is MQP.
Related Clinical Trials
Other Devices by Medtronic Sofamor Danek USA, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.